10,000 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional)
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·NaviStar THERMOCOOL Deflectable Diagnostic/Ablation Catheter
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·OBALON BALLOON SYSTEM
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NeuroPace RNS System
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·Obalon Balloon System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·BIOBURDEN TESTING
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·MULTILINK ZETA/PIXEL & ULTRA CORONARY STENT SYSTEMS
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·ACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEMS
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·TALENT ABDOMINAL STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES(IOLS), CEEON 911A, 913A & TECNIS Z9000,Z9001
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Mentor Memory Shape Breast Implants
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·S670/S660/BESTENT(TM)2 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS ACRYLIC IOLS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·SILICONE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·FORTIFY DR / VR ICD SYSTEMS
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MINIMED 630G pump
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CADENCE FAMILY OF ICDS